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By Louis Garguilo, Chief Editor, Outsourced Pharma | Clinical trials are not my beat, but the BIOSECURE Act targeting CDMOs sure is. Now the congressional committee involved with putting that legislation together has found something of perhaps more substance, and better substantiated, to add to the impetus of the Act: clinical trials in China. |
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The High Life And Times Of a Qualified Person (QP) In Europe | By Louis Garguilo, Chief Editor, Outsourced Pharma | You must be appropriately qualified, trained, accepted by the relevant competent authority in the European Union, and named on a site’s authorization. According to Nolliag Buckley, a Qualified Person (QP) also needs more. “Honest to God, you must be creative. That sort of individual skill is helpful. I'm a troubleshooter. That's what I love.” |
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VR/XR In Drug Manufacturing: No Longer Sci-Fi | By Erika L. Roberts, ELR Lab Services LLC | Virtual reality (VR) immerses users in a completely simulated environment, while extended reality (XR) is an umbrella term encompassing VR, augmented reality, and mixed reality. These capabilities open up a world of possibilities for drug manufacturing. |
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Ensuring The Efficacy Of Probiotic Products | Article | Ropack Pharma Solutions | Without proper handling and packaging, probiotics can be compromised at any point in the packaging, storage, and transportation process, impacting shelf life and efficacy. |
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Drug Substance Or API Manufacturing | Pharma Expanse | Our network currently spans across 9 manufacturing sites in 5 countries and can support discovery, preclinical, clinical and commercial programs for NCEs. Review our API capabilities below and contact us to simplify your outsourcing solutions. |
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OUTSOURCED PHARMA CAPACITY UPDATE |
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CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs. |
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